BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 14842420 · Received June 28, 2022

    Report

    Report Number
    1067162-2022-00004
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    May 30, 2022
    Report Date
    June 28, 2022
    Manufacturer
    RHYTHMLINK INTERNATIONAL, LLC
    Product Code
    GXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A (BROKEN OFF) ELECTRODE WAS RETAINED IN THE PATIENT, AND HAD TO BE SURGICALLY REMOVED FROM THE PATIENT ABOUT 1 WEEK AFTER SURGERY. THE CUSTOMER DID NOT PROVIDE INFORMATION ON THE ELECTRODE PART NUMBER OR LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735115 UNKNOWN SUBDERMAL NEEDLE ELECTRODE GXZ RHYTHMLINK INTERNATIONAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other